Effect of Exercise Based Regimen on Frailty in Children With Liver Disease

NCT05770284 | Completed

• 1 other identifier: ILBS-Liver Disease-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is now a well-known complication of liver disease and various studies, including pediatric literature studies, have recognized it as a poor prognostic factor in CLD as well as liver transplant settings. It is associated with poor quality of life, increased hospitalisation and mortality. Exercise for \>12 weeks leads to improvements in aerobic power (peak VO2), aerobic endurance, muscle mass and strength, health related quality of life (HRQoL)(1). Although effect of Exercise on sarcopenia and frailty has been studied extensively in cirrhotic adults, there is paucity of such literature on the effect of exercise on frailty in children. Through this study, we aim to assess efficacy of exercise-based regimen on frailty in children with chronic liver disease after 12 weeks. Our secondary objective will be to compare outcome between the two groups(frail and non frail children with liver disease) and to compare change in frailty scores between the two groups. Other objectives will include assessment of the body composition analysis and the myokines and hepatokines signatures of children with liver disease (pre and post exercise intervention).

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (2)

• Prevalence of Frailty in children with liver disease.

  Fraility assessment criteria will be based on 5 elements: 1. weakness will be assessed by grip strength. 2. slowness will be by 6 minutes walk test. 3. shrinkage by triceps fold thickness. 4. exhaustion by validated pediatric PedsQL 4.0 multidiamential fatigue scale. 5. diminshed physical activity by modified PAQ

  0 day

• Improvement in Frailty after 12 weeks of exercise therapy in children with CLD and Frailty.

  Improvement will be based on five fried fraility criteria with fraility score\> 5

  12 weeks

Secondary Outcomes (9)

• Increase in skeletal muscle mass in Body composition analysis after 12 weeks of exercise regimen

  12 weeks

• Decrease in the occurrence of Hepatic Encephalopathy based on modified West Haven criteria in the exercise regimen with SMT group versus SMT alone.

  3 months

• Decrease in the occurrence of Upper Gastrointestinal bleed (presence or absence of GI bleed) in the exercise regimen with SMT group versus SMT alone.

  3 months

• Decrease in the occurrence of significant events including Spontaneous Bacterial Peritonitis in the exercise regimen with SMT group versus SMT alone .

  3 months

• Decrease in the occurrence of significant events including Acute Kidney Injury in the exercise regimen with SMT group versus SMT alone .

  3 months

Study Arms (2)

Subject will receive 12 weeks of exercise with standard medical management (SMT)

EXPERIMENTAL

* Subjects will be given exercise protocol Pre-exercise safety assessment: Careful assessment as per exclusion criteria; especially Portal Hypertension, Cardiopulmonary status etc * Frequency: Aerobic and Resistance Exercises for total 50 minutes/day for 2-5 days per week (see protocol) * Aerobic exercises consist of Brisk walking * Resistance Exercises consist of movements targeting the major muscle groups with weight lifting * Intensity: Talk test: Short of breath but still can speak a full sentence Borg Scale: Keep between 5-6 out of 10. * Time duration of aerobic exercise decided by 6MWT, and resistance exercise by Hand grip strength * End point: 12 weeks * Stopping rule: * Interruption of Exercise for \> 7 consecutive days due to non-compliance or clinical events. * Progression to exclusion criteria i.e. decompensation etc Both groups will be advised a calorie intake of 150cal/kg/day and protein intake of 3 gm/kg/day

Other: 12 weeks exercise; Other: Standard Medical Treatment

standard medical management (SMT)

ACTIVE COMPARATOR

standard medical management (SMT)

Other: Standard Medical Treatment

Interventions

12 weeks exercise OTHER

12 weeks exercise

Subject will receive 12 weeks of exercise with standard medical management (SMT)

Standard Medical Treatment OTHER

Standard Medical Treatment

Subject will receive 12 weeks of exercise with standard medical management (SMT); standard medical management (SMT)

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children 9 - 18 years age with chronic liver disease \& frailty score \> 5.

You may not qualify if:

• Lansky play performance scale \<50
• Unable to do exercise under supervision on at least 2 occasions
• Children on higher corticosteroid dose (\>0.1mg/kg/day) in last 12 weeks
• Any degree of musculoskeletal involvement (myopathy/limb deformity/paraplegia)
• Children with any cardiac disease
• Children with neurological Wilson
• Uncontrolled portal hypertension (persistent high-risk varices) Recurrent variceal bleed ≥ 2
• Any degree of hemodynamic instability
• Current hepatic encephalopathy (any grade)
• Grade 3 ascites
• Hepatic hydrothorax
• Any degree of oxygen dependence
• Severe or Very severe Hepatopulmonary syndrome (room air PaO2 \< 60 mm Hg).

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 15, 2023
• Study Start: March 15, 2023
• Primary Completion: November 2, 2024
• Study Completion: November 2, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

IN (1)